“Look both ways before you cross the road.” At an early age, we all learn that there’s no such thing as being too safe.
The same philosophy applies to designing and manufacturing medical devices. In this article, we’ll look at how a sterilization indicator adds a crucial second layer of safety to your medical gasket.
What are printed sterilization indicators?
Printed indicators feature functional inks that change color when exposed to a specific environmental or chemical change. For sterilization indicators, that means providing visual confirmation that the device underwent a sterilization process, such as turning from pink to brown, or blue to green.
Printed indicators can be designed to verify common sterilization methods used on medical devices, including steam and ethylene oxide (EO).
Benefits of sterilization indicators for Medical gaskets
One of the benefits of some medical connectors, like in genderless aseptic connectors, is providing a sterile connection, even in unsterilized environments. However, you can never be too safe when it comes to medical applications such as fluid transfer. Including a sterilization indicator on the connector gasket provides secondary protection.
- Verification of sterility – At a glance, the medical provider can get visual assurance that the component has been sterilized and is safe to use.
- Improved quality control – Sterilization indicators reduce the risk of contamination and use of dysfunctional connectors.
- Enhanced care – Medical providers can work more efficiently and confidently using medical gaskets with sterilization indicators.
- Compliance with regulations – Sterilization indicators may help the product meet FDA or other requirements.
Overcome production challenges with the right manufacturing partner
The advantages of sterilization indicators are clear (pun intended). But what about the downsides?
Manufacturing medical gaskets is already complex – and a sterilization indicator adds to the complexity. Significant considerations include material selection of the functional ink and membrane substrate. Plus, printing the sterilization indicator requires another process for the multi-layer construction.
While this may seem daunting from a production standpoint, sterilization indicators provide critical functionality and peace of mind to the final product. It also helps to have the right manufacturing partner on your side.
At Tapecon, we have extensive experience incorporating printed indicators in medical devices, including connector gaskets. Talk to our expert team about material selection and how we can efficiently manufacture your custom gasket in our FDA-registered facility.
Let’s make something great
With over 100 years of manufacturing experience, Tapecon works with product teams to solve challenges, create products, and enhance lives. Learn more about our gaskets and filtration applications.
